Rock Talk

Charting a Renewed Course for Managing Financial Conflicts of Interest

I’m very pleased to announce that the Department of Health and Human Services is issuing a final rule in the Federal Register revising the regulations on financial conflicts of interest of extramural investigators. The regulations, one of which applies to grants and cooperative agreements and the other to contracts, were first published in 1995, and with your input we have been working on revising them for the past several years.

The impetus for revising the regulations stemmed from many sources. We recognized that biomedical and behavioral research and the resulting interactions among government, research institutions, and the private sector have become increasing complex. While these interactions are often essential to the process of moving discoveries from the bench to the bedside, it can be challenging to manage the resulting financial relationships when federal funds are also involved so as to assure the public that they can trust in the objectivity of the research.

At the same time, there has been increased scrutiny of investigators’ financial relationships from Congress and the public, as well as the general principle of providing increased transparency and accountability in the use of all federal funds.

These factors highlighted the need to revisit the 1995 regulations. The process began with an Advance Notice of Proposed Rulemaking (ANPRM) in May 2009 asking the community whether the rule should be revised, and if so, how it might be strengthened. After considering these comments, we published a Notice of Proposed Rulemaking (NPRM) in May 2010 that proposed specific revisions to the regulations and again asked for your input.

The community provided numerous and very thoughtful comments. We considered them carefully when preparing the revised regulations. The same general framework of the 1995 regulation has been maintained:

Institutions are responsible for implementing the regulations by their financial conflict of interest policy, evaluating their investigators’ significant financial interests, determining and managing financial conflicts of interest, and reporting financial conflicts of interest to the NIH.

Investigators are responsible for complying with the institution’s policy, disclosing their significant financial interests, and complying with the institution’s management of any financial conflicts of interest.

NIH’s role remains to provide guidance and oversight.

However, the revised regulations do institute a more rigorous approach to the management of investigator significant financial interests and resulting financial conflicts of interest to enhance the objectivity and integrity of the research process. These include changes to address investigator disclosure, institutional management of financial conflicts of interest, and federal oversight. In particular, the regulations:

Require investigators to disclose to their institutions all of their significant financial interests related to their institutional responsibilities as opposed to only those that they see as related to Public Health Service (PHS)-supported research.

Lower the monetary threshold for disclosure of significant financial interests, generally from $10,000 to $5,000.

Require institutions to report to the PHS awarding component more comprehensively on identified financial conflicts of interest and how they are being managed.

Require institutions to make certain information concerning identified financial conflicts of interest held by senior/key personnel accessible to the public.

Require investigators to be trained on the regulations and their institution’s financial conflict of interest policy at designated times.

We recognize that it will require commitment and careful deliberation by both investigators and institutions to comply with these changes. Therefore, we have provided an implementation period of up to one year (see final rule for the exact language). Until your implementation is complete, you should continue to comply with the 1995 regulations. We are developing training materials for the community, including frequently asked questions and a tutorial. These will be posted on the Financial Conflict of Interest website in the coming weeks.

Looking back over the long road we’ve taken to get to this point, I am very grateful for the substantive and thoughtful comments you provided to both the ANPRM and the NPRM. They were invaluable in our efforts to draft regulations that provide greater transparency and accountability, are not overly burdensome, and that allow those so important relationships between NIH-funded researchers and industry to continue in a venue of integrity and objectivity.

5 thoughts on “Charting a Renewed Course for Managing Financial Conflicts of Interest”

Given that the scandals of greatest importance (to the tune of hundreds of thousands in consulting fees, scientists in a position to significantly influence clinical drugs, prescribing practices, etc) involve PIs who ignored the reporting rules in place at the time…what is this going to solve?

Not much, but for the thousands of researchers in the US, another unfunded mandate for training, even if it only takes an additional 1 hour of mandated training will probably cost 100,000 hours (or more) at $50 to $100 per hour is a mere five to ten million dollars which comes out of the research productivity of US. So with 2 hours of diversity training, 2 hours of IRB training, 1 hour of COI training plus other mandates, we could be spending a quarter of a billion dollars to prevent “abuse”. I guess with the cuts in support for education from every direction, we can look at these cuts as saving money by thinning the workforce. Some day, we will begin to ask the cost/benefit or cost/effectiveness of the rules.

The increase in regulatory compliance will increase the indirect cost for institutions. Was there a study to determine the cost of compliance for this rule? Rulemaking is easy when you do not have to pay for the compliance because you do not know the impact. I wonder how many fewer grants and contracts will be awarded due to increasing cost for this rule. Its not just not one rule, its the culmination of compliance on research institututions for many that does not directly effect safety of patients but the intent is to increase ‘transparancy’. Though the intent to prevent abuse is well meaning. I have good reason for being sceptical in that I know my counterparts in academia have expressed increased overload with overhead and non direct staff to comply with rules at their institutions. Yet we turn a blind eye on regulatory compliance at the foreign institutions. This seems to be an disadvantage for American institutions…

New COI regulations are welcome but this final rule fails to articulate the PHS’s responsibilities. Institutions must report to the PHS awarding unit but there is no indication how those units will manage the reports. Will institutions be told that management plans are acceptable or unacceptable? Is no news from the PHS unit good news? How will different PHS units assure consistency in what constitutes an acceptable management plan for different types of conflicts?

The new rules set new standards for reporting but not for management. This approach will continue to permit uncertainty and broad variability between institutions on how COI issues are managed.

Corporate and especially pharmaceutical money has thoroughly corrupted the practice of medicine and medical research. It is imperative that we work to eliminate conflicts of interest to the extent we can, and manage or limit them when we cannot. Arguing that people and institutions don’t have the time or resources to report large sums of potentially corrupting money sounds like the same argument that tax cheats and corrupt politicians tend to put forth. If you aren’t conflicted, then check that box. If you are, and you intend to influence scientific discourse, then we need to know. Research institutions get millions in indirect costs on research grants. We can and must keep track of undue influence if we are to conduct science with integrity.